Is Myopathy Part of Statin Therapy (IMPOSTER-16)
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Purpose
There is a significant proportion of patients complaining of muscle symptoms while on statin therapy who have a measurable difference in muscle strength or endurance and whose muscle biopsies are diagnostic for myopathy.
| Condition | Intervention | Phase |
|---|---|---|
|
Myopathic Conditions |
Drug: cellulose placebo vs. atorvastatin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Diagnostic |
| Official Title: | Double Blind, Prospective Randomized, Crossover Study of Patients With Muscle Complaints on Statin Therapy |
- hip flexion [ Time Frame: 8 weeks ]
- grip strength [ Time Frame: 8 weeks ]
- oxygen consumption and anaerobic threshold [ Time Frame: 8 weeks ]
- muscle pathology score [ Time Frame: at entry ]
- ability to identify blinded statin [ Time Frame: 8 weeks ]
- other aerobic exercise indexes [ Time Frame: 8 weeks ]
- fatty acid oxidation of myocyte cell cultures [ Time Frame: at entry ]
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2005 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 1 |
Drug: cellulose placebo vs. atorvastatin
drug
Other Name: atorvastatin
|
|
Active Comparator: 2
statin administration
|
Drug: cellulose placebo vs. atorvastatin
drug
Other Name: atorvastatin
|
Detailed Description:
This is a double-blinded, randomized, placebo-controlled, crossover trial. Sixty patients who are identified by their physician as having muscle pain or weakness while on statin therapy and in whom creatine kinase (CK) enzyme determinations have been normal will be enrolled voluntarily. All patients will have a percutaneous muscle biopsy prior to enrollment into the trial. These patients will be randomized in a blinded crossover fashion to either standardized statin therapy or placebo in eight week intervals. After eight weeks of drug or placebo the patients will be assessed for signs and symptoms of muscle weakness by:
- Dynamometry of grip and hip strength
- An exercise test with exhaled gas analysis
- Blood tests for cholesterol, creatine kinase, lactate
- Urine tests for organic acids
Following the first eight-week study and testing period, each patient will serve as their own control and they will enter a second eight-week study period. During the second phase they will take the opposite therapy, either drug or placebo, which they have not yet received. Sub-studies will include ten controls who have never previously received statins and ten subjects who have suffered statin-induced rhabdomyolysis. Subjects in these sub-studies will not be exposed to statin therapy and will only undergo limited testing.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Primary doctor's permission
- Patient understands nature of study and has signed consent
- Patient is >21 years of age
- Patient willing to stop statin for up to 12 weeks and remain off CoQ10 for study duration
- Patient able to perform the strength and functional tests required
- Patient complains of muscle weakness or aching which he/she or his/her physician feels may be attributable to statin therapy
- CK < 350 IU
- Thyroid stimulating hormone (TSH) must be normal
- Fasting respiratory exchange ratio (RER) > 0.80 off statin for at least 4 weeks
Exclusion Criteria:
- Severe underlying illness including: Cr > 3.0, liver failure, unstable angina, symptomatic valvular heart disease, congestive heart failure, or prior cerebrovascular accident (CVA) preventing exercise testing.
- History of muscle damage (CK > 350 IU) on statins
- Underlying musculoskeletal disorder preventing muscle testing
- History of severe depression
- Taking doses of other medicines with statin sufficient to cause myopathy including: cyclosporine, erythromycin or other macrolide antibiotics; fluconazole; niacin; fibrates; or > 16 oz. of grapefruit juice daily.
- Diabetes requiring other than diet therapy
- Use of thiazolidinediones (TZD's), protease inhibitors or other drugs known to influence RER or fatty acid oxidation.
- Abnormal thyroid status
- Inability to maintain constant exercise, dietary, and drug regimen during the 16 weeks required by the study protocol.
Contacts and Locations| United States, California | |
| Scripps Mercy Hospital | |
| San Diego, California, United States, 92103 | |
| Principal Investigator: | Paul S Phillips, MD | Scripps Health |
| Study Director: | Harminder Sikand, PharmD | Scripps Mercy |
More Information
Publications:
| Responsible Party: | Paul Phillips,, MD, Scripps Health - Scripps Mercy Hospital |
| ClinicalTrials.gov Identifier: | NCT00127335 History of Changes |
| Other Study ID Numbers: | M-05-001 (MER004241) |
| Study First Received: | August 4, 2005 |
| Last Updated: | July 26, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Scripps Health:
|
rhabdomyolysis, myositis, myopathy, |
statin side effects, fatty acid oxidation Statin induced Muscle toxicity |
Additional relevant MeSH terms:
|
Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Nervous System Diseases Atorvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013